Metabolic Syndrome, Physical Activity, Prostate Cancer
Conditions
Keywords
prostate cancer, African-American, Metabolic Syndrome, Exercise, Men's Health
Brief summary
The main purpose of this study is to examine the feasibility of an exercise intervention on metabolic syndrome (MetS) components and biomarkers related to prostate cancer in Black men with MetS who are at increased risk of prostate cancer.
Detailed description
The specific aim for the proposed study is to examine the feasibility and impact of a 6-month two-arm randomized controlled trial (RCT) on MetS components and biomarkers related to prostate cancer in Black men with MetS. Due to the striking racial disparities of prostate cancer, this proposal will focus on the impact of an aerobic and resistance exercise intervention on MetS and biomarkers related to prostate cancer in Black men. Specifically, our proposed clinical trial compares an aerobic and resistance exercise intervention to an attention control group among Black men.
Interventions
BEHAVIORALExercise
For the first 12-weeks, participants will come to our community based research office for up to 50 min/session, 3-days/week of supervised exercise. Exercise duration will increase from 75 min/wk at week 1 to 150 min/wk by week 4. Thereafter, men will maintain 150 min/wk of moderate-intensity physical activity.
BEHAVIORALAttention Control
We will provide weekly healthy lifestyle tips via text messages, and will include tips such as managing stressors in life and getting better sleep.
Sponsors
Georgetown University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
40 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
1. African-American and/or Black men; 2. between the ages of 40-70 years; 3. waist circumference \>40 inches (102 cm); 4. with at least two of the following: elevated BP (≥ 130/85 mmHg); 5. elevated fasting glucose (≥ 100 mg/dL), reduced HDL cholesterol (\<50 mg/dL), or elevated triglycerides (≥ 150 mg/dL); 6. sedentary defined as \<60 minutes of recreation or work requiring modest PA/week; 7. be able to speak and read English; 8. able to provide meaningful consent (i.e., men with severe cognitive impairment will be excluded); 9. have no physical limitations that prevent from exercising; 10. and have access to a television and DVD player.
Exclusion criteria
1. history of cancer except nonmelanoma skin cancer; 2. current enrollment in another clinical trial or weight loss program; 3. inability to commit to the intervention schedule. Prior to randomization, participants will be required to have a signed authorization and medical clearance from their personal physician or our nurse practitioner.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Waist circumference | 6-months | Waist circumference will be measured at baseline, 3- and 6-months of the intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular fitness test | 6-months | Bruce treadmill protocol will be used to determine VO2max at baseline, 3- and 6-months of the intervention. |
| Fasting glucose levels test | 6-months | Fasting blood sample via finger sticks will be administered by a phlebotomist to measure fasting glucose levels at baseline, 3- and 6-months of the intervention. |
| Dietary behaviors questionnaire | 6-months | Block 2005 Food Frequency Questionnaires (FFQ) at baseline, 3- and 6-months of the intervention |
| Quality of life questionnaire (SF-36) | 6-months | Short Form 36 Health Survey (SF-36) will be administered at baseline, 3- and 6-months of the intervention. |
| Body Mass Index (BMI) | 6-months | Weight (lbs) and height (inches) will be measured to calculate BMI at baseline, 3- and 6-months of the intervention. |
| Lipid level test | 6-months | Fasting blood sample via finger sticks will be administered by a phlebotomist to measure lipid levels at baseline, 3- and 6-months of the intervention. |
Countries
United States
Outcome results
None listed